K232803
- 510(k) number
- K232803
- Device name
- NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
- Applicant
- Nxstage Medical, Inc. MA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2024-03-14
- Date received
- 2023-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232803.pdf
Official FDA record: K232803
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.